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Dermbits

BI Spevigo September 2023

DO, MPH

Which patients are recommended for treatment with spesolimab, and are there any exclusions? 

Generalized Pustular Psoriasis (GPP)

You. If we look at the clinical trials for spizolamob, the inclusion criteria, first of all started with adult patients and those were 18 years of age, up to 75 years of age. And in terms of inclusions, they had to have new appearance or worsening of their pustules and they needed to have a generalized postulous psoriasis physicians global assess of greater than or equal to three pustules. They also were required to have a GPP, PGA or generalized pustulous psoriasis physicians global assessment postulation subscore of greater than or equal to two. They also were required to have a minimum of 5% body surface area covered with erythema and the presence of what we like to call those monomorphic pustules that we see with patients classically with GPP. Now, what were some of the exclusions? Well, anything that was a drug event triggering postules that look like GPP, such as the so called acute generalized execmatis postulosis, any immediate life threatening GPP, at least for the trials, that was a flare requiring an intensive care unit admission if they had dose escalation of a treatment that we were using previously, like cyclosporin retinoids, methotrexate within two weeks of initiation of the trial, prior to randomization, and in terms of systemic therapy that also includes biologic therapies.

Which patients are recommended for treatment with spesolimab, and are there any exclusions?

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